Tissue Diagnostics Market

The global tissue diagnostics market in terms of revenue was estimated to be worth $5.6 billion in 2023 and is poised to reach $8.4 billion by 2028, growing at a CAGR of 8.4% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is driven by the growing private diagnostic centers globally, and rising geriatric population with subsequent growth in chronic and infectious diseases. On the other hand, high degree of consolidation and high cost of diagnostic imaging system are expected to restrain the growth of this market to a certain extent.

Tissue Diagnostics Market Size, Dynamics & Ecosystem

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Tissue Diagnostics Market Dynamics

DRIVER: Growing demand for digital pathology

Digital pathology systems are increasingly being utilized by healthcare professionals across the globe due to the ongoing trend of automation of diagnostic laboratory processes across major healthcare markets. Moreover, improved laboratory efficiency is critical for healthcare providers and patients for accurate and timely disease diagnosis to devise effective disease management strategies. With the greater utilization of digital and automated processes, laboratory technicians can offer accurate and affordable disease diagnoses in a time-bound manner. As a result, major healthcare service providers are adopting digital pathology systems and related software to offer efficient and affordable services to their customers.

Globally, governments and industry entities are directing their attention toward diverse strategies within the realm of digital pathology, aiming to offer highly advanced, swift, and precise diagnostic solutions. Highlighted are key advancements which mentioned in below:

• In January 2023, Agilent Technologies, Inc. has entered into a partnership with Akoya Biosciences, Inc. to develop multiplex-immunohistochemistry diagnostic solutions. This collaboration intends to commercialize workflow solutions for multiplex assays dedicated to tissue analysis, ultimately providing a comprehensive multiplex IHC solution for biomarker clinical research, facilitated by digital pathology.
• In June 2022, Roche introduced the VENTANA DP 600 slide scanner, a digital pathology system designed for generating digital representations of stained tissue samples.

These advancements, coupled with the emergence of high-tech and diagnostic firms, are anticipated to drive market growth.

RESTRAINT: Stringent Regulatory requirement

The FDA's current approval process for tissue diagnostic tools and consumables poses a significant hurdle for companies aiming to introduce innovative products. Many of these fall under Class III, requiring exhaustive Premarket Approval (PMA) that scrutinizes safety and effectiveness, marking the most rigorous application route.

The recent release of FDA guidance documents further adds to the complexity. Any alterations to devices demand a 510(k) submission, whether for software updates, installations, or other modifications. Meanwhile, in the EU, In Vitro Diagnostic (IVD) products adhere to a distinct regulation, with the forthcoming Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) adding more stringent criteria for CE Marking, crucial for market legality.

Aligning with these stringent regulations presents a challenge for market players. Adapting processes to comply with these norms may affect the launch timelines for new products, especially in the US and Europe, potentially creating temporary market entry delays.

OPPORTUNITY: Significant opportunities in BRICS Countries

Growing markets like India, China, and Brazil are poised to become pivotal growth arenas for industry stakeholders in the foreseeable future. As per SRB's analysis, the BRICS nations are projected to collectively contribute 50% to the global GDP by 2030, with a combined annual GDP of USD 24,142,139 million in 2021. Notably, each of these nations has seen consistent annual GDP increases; for instance, China's GDP has surged nearly sixfold since 2003. This economic upswing is anticipated to fuel expansion in the healthcare sector, presenting lucrative prospects for participants in the market.

Furthermore, the sizable population base, especially in India and China, forms a sustainable diagnostic market. Lifestyle shifts and suboptimal diets in these regions have elevated the prevalence of chronic ailments such as cancer, cardiovascular diseases (CVDs), and autoimmune disorders. The rising incidence of chronic conditions, coupled with a substantial patient pool in these regions and augmented healthcare spending, is set to create substantial growth avenues for market players. For instance, the NIH estimates India had 1,461,427 cancer patients in 2022. Similarly, China accounted for 24% of newly diagnosed cases and 30% of global cancer-related deaths in 2020, according to PubMed. The higher mortality rates are linked to undiagnosed cases, a shortage of diagnostic labs, and insufficient histopathologists in these regions.

CHALLENGE: Lack of Infrastructure and low awareness in middle and low income countries

The burden of cancer and other non-communicable diseases is very high in developing and underdeveloped countries. However, there is a glaring disparity in the access to care and health indicators in these countries as compared to their developed counterparts. This can be attributed to the lack of access to care, the limited availability of resources in terms of infrastructure and manpower, a lack of awareness, and the social stigma associated with cancer. According to the WHO, 44% of the WHO member states report having less than 1 physician per 1000 population. Similarly, according to the 2022 OECD data, China and India, respectively recorded doctor densities of 2.5 and 0.9 doctors per 1,000 people. There is a disproportionate distribution of health workers worldwide. Countries having the lowest relative need to have the highest numbers of health workers, while those with the highest disease burden have a smaller health workforce. The African region has more than 24% of the total global burden of disease but has access to only 3% of health workers and less than 1% of the world’s financial resources.

Tissue Diagnostics Market Segmentation & Geographical Spread

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In 2022, Consumables accounted for the largest share in the tissue diagnostics industry, by product.

Based on product, the tissue diagnostics market is segmented into consumables and instruments. Consumables accounted for the largest share of the market in 2022 by product segment. The rise in government and private funding in life sciences and cancer research and growing R&D expenditure by leading pharma companies, are factors expected to drive the growth of this products segment.

In 2022, Immunohistochemistry accounted for the largest share in the tissue diagnostics industry, by technology.

Based on technology, the tissue diagnostics market is segmented into four technology segments, namely, Immunohistochemistry (IHC), In Situ Hybridization (ISH), Digital Pathology & Workflow, and Special Staining. Immunohistochemistry (IHC), accounted for the largest share of the market in 2022 by technology. In IHC technique the antibodies are used to test certain antigens in tissue by combining immunological, anatomical, and biochemical techniques. The detection of antigens is achieved by using antibodies that bind to antigens with high specificity. This technology is widely used in the diagnosis of abnormal cells.

In 2022, Breast Cancer segment accounted for the largest share in the tissue diagnostics industry, by disease type.

Based on disease type, the tissue diagnostics market is segmented into six disease segments, namely, breast cancer, gastric cancer, lymphoma, prostate cancer, non-small cell lung cancer, and other disease types. In 2022, breast cancer accounted for the largest share of the market, by disease type. A number of factors led to the formation of breast cancer such as age, change in lifestyle and the use of hormone replacement therapy. Moreover, with a rise in breast cancer screening activities, the segment is expected to witness considerable growth during the forecast period.

In 2022, hospitals accounted for the largest share in the tissue diagnostics industry, by end user.”

Based on end user, the tissue diagnostics market is segmented into Hospitals, Pharmaceutical Companies, Research Laboratories, Contract Research Organizations, and Other End Users. Hospitals accounted for the largest share of the market by end user. The share of the end user segment is owing to the rise in prevalence of cancer and infectious diseases, which require Multi-specialty hospitals, cancer specialty hospitals, or cancer treatment centers. Hospitals generally have in-house laboratories that perform various types of diagnostics & monitoring tests that enable faster and reliable results.

In 2022, North America accounted for the largest share of the tissue diagnostics industry.

Based on Region, The global tissue diagnostics market is segmented into four regions: North America, Europe, Asia Pacific, and Rest of the world. North America accounted for the largest share of the market in 2022. The increasing healthcare expenditure, and high-quality infrastructure for hospitals and clinical laboratories in the region are the major factors driving the growth of market in North America.

The major players in tissue diagnostics market are F. Hoffmann-La Roche Ltd (Switzerland), Danaher Corporation (US), PHC Holdings Corporation (Japan), Agilent Technologies Inc. (US), Thermo Fisher Scientific, Inc. (US), These players’ market leadership is due to their broad product portfolios and vast global footprint. These dominant market players have advantages, including strong research and development budgets, better marketing and distribution networks, and established brand recognition.

Scope of the Tissue Diagnostics Industry

This report categorizes the tissue diagnostics market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Consumables
  • Antibodies
  • Kits
  • Reagents
  • Probes
• Instruments
  • Slide-staining Systems
  • Scanners
  • Tissue-processing Systems
  • Other Instruments (automated cover slippers, microtomes, embedding systems, paraffin dispensers, and slide labelers)

By Technology

• Immunohistochemistry
• In Situ Hybridization
• Digital Pathology & Workflow Management
• Special Staining

By Disease Type

• Breast Cancer
• Gastric Cancer
• Lymphoma
• Prostate Cancer
• Non-small Cell Lung Cancer
• Other Disease Types (neurological disease, cardiovascular disease, immunological diseases, infectious diseases, cancers of the bone, colon, thyroid, cervix, and skin; gallbladder carcinoma; HBV; Epstein-Barr virus; hepatitis; muscular dystrophy; renal cell carcinoma; and pleomorphic sarcomas.)

By End User

• Hospitals
• Research Laboratories
• Pharmaceutical Companies
• Contract Research Organizations (CROs)
• Other End Users (reference laboratories and academic research laboratories)

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Rest of Asia Pacific
• Rest of The World (RoW)
  • Latin America
  • Middle East & Africa

Recent Developments of Tissue Diagnostics Industry

• In April 2023, Leica Biosystems received FDA clearance for BOND MMR Antibody Panel, for detection of colorectal cancer.
• In April 2023, Leica Biosystems launched its BOND-PRIME an advanced staining solution for increasing diagnostic productivity in the lab
• In February 2023, F. Hoffman-La Roche Ltd launched its IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody and the ATRX Rabbit Polyclonal Antibody for use in the BenchMark series of instruments for the detection of brain cancer.
• In October 2022, F. Hoffman-La Roche Ltd received FDA approval for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody use as a companion diagnostic test to identify metastatic breast cancer patients with low HER2 expression.
• In August 2022, F. Hoffman-La Roche Ltd (Switzerland) received FDA approval its for label expansion for the VENTANA MMR RxDx Panel.

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